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The effects of vitamin D or iron-vitamin supplementation on bone metabolism and inflammation in 18-40-year women

Protocol summary

Summary
The present study will investigate the effects of vitamin D supplementation alone or in combination with iron on bone metabolism and inflammation in women. The inclusion criteria will be simultaneous anemia and vitamin D deficiency. Subjects will be excluded if they have hematologic diseases. Ninety women (aged 18-40) will be randomly assigned to one of two treatments: 1000IU vitamin D plus 27mg elemental iron or 1000IU vitamin D plus placebo every day for 3 months. Blood samples will be collected at baseline and the end of the study and stored at -80 oC. They will be asked to complete a 3 days food record and physical activity questionnaire at the beginning, middle and end of the study. To assess the effect of intervention on anxiety and depression, the Beck Depression Inventory will be used. Blood pressure, body weight, and height will be measured, too. Blood venous samples will be taken after 12hr fasting. CBC, Ferritin, Serum iron, Transferrin, Ttransferrin saturation, OC, PTH, CTx, ALP, 25(OH)D, TIBC, and hsCRP will be assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201409082365N9
Registration date: 2014-10-27, 1393/08/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-10-27, 1393/08/05
Registrant information
Name
Mohammad Reza Vafa
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4734
Email address
vafa.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-10-11, 1393/07/19
Expected recruitment end date
2014-11-10, 1393/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of vitamin D or iron-vitamin supplementation on bone metabolism and inflammation in 18-40-year women
Public title
The effect of vitamin D plus iron vs. vitamin D on bone health and inflammation in women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Healthy; Non-smoker; Non-pregnant; Non-lactating; Body mass index: 18.5-29.9 kg/m2; Ferritin less than 30 ng/ml; Hemoglobin less than 12 g/dl; 25 hydroxy vitamin D less than 30 ng/ml. Exclusion criteria: Amenorrhea; Menopause; Minor Thalasemia; Hemochromatosis; Inflammatory bowel diseases; Crohn's disease; Gastric ulcer; Celiac disease; Gastrointestinal bleeding diseases; Renal diseases; Blood donation during past 3 months; Iron or Vitamin D supplement use during past 3 months.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee at Isfahan University of Medical Sciences
Street address
Isfahan University Of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
81754
Approval date
2014-09-07, 1393/06/16
Ethics committee reference number
D/98/340

Health conditions studied

1

Description of health condition studied
Association between iron supplementation and vitamin D or vitamin D alone on bone metabolism and inflammation in women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
25 hydroxy vitamin D
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

Secondary outcomes

1

Description
Hematocrit
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

2

Description
Mean Cell Vollum
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

3

Description
Hemoglobin
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

4

Description
Serum iron
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

5

Description
Ferritin
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

6

Description
Transferrin
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

7

Description
Transferrin saturation
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

8

Description
Total Iron Binding Capacity
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

9

Description
Alkaline phosphatase
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

10

Description
Parathyroid hormone
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

11

Description
C-terminal telopetide x
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

12

Description
Osteocalcin
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

13

Description
Highly-sensitive C Reactive Protein
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

14

Description
Tumor Necrosis Factor Alpha
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

15

Description
Interleukin 6
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

16

Description
Total Antioxidant Capacity
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

17

Description
Malodialdehyde
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

18

Description
Lipid profile
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

19

Description
Fasting Blood Sugar
Timepoint
At baseline and the end of the study
Method of measurement
Blood sample

Intervention groups

1

Description
Intervention group participants will be prescribed two tablets (one 1000 international unit vitamin D plus one 27 mg elemental iron every day). They will instructed to take the tablets separately.
Category
Treatment - Drugs

2

Description
Control group participants will be prescribed two tablets (one 1000 international unit vitamin D plus one placebo every day). They will instructed to take the tablets separately.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran University of Medical Sciences faculties and dorms
Full name of responsible person
Dr Mohammadreza Vafa
Street address
Nutrition and health group, Faculty of health, Iran University of Medical Sciences, Hemmat highway, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Sayyed Morteza Safavi
Street address
Department of clinical nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Nutrition and health group
Full name of responsible person
Dr Mohammadreza Vafa
Position
PhD of nutrition, Professor
Other areas of specialty/work
Street address
Nutrition and health group, Faculty of health, Iran University of Medical Sciences, Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Phone
+218 6704734
Fax
Email
rezavafa@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nutrition and health group
Full name of responsible person
Dr Mohammadreza Vafa
Position
PhD of nutrition, Professor
Other areas of specialty/work
Street address
Nutrition and health group, Faculty of health, Iran University of Medical Sciences, Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Phone
+218 6704734
Fax
Email
rezavafa@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nutrition and health group
Full name of responsible person
Dr Mohammadreza Vafa
Position
Phd of nutrition, Professor
Other areas of specialty/work
Street address
Nutrition and health group, Faculty of health, Iran University of Medical Sciences, Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Phone
00
Fax
Email
rezavafa@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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